THE FRENCH EXPERIENCE OF TREATMENT OF CHRONIC TYPE-D HEPATITIS WITH A12-MONTH COURSE OF INTERFERON-ALPHA-2B - RESULTS OF A RANDOMIZED CONTROLLED TRIAL

Hepatitis due to hepatitis delta virus (HDV) infection is generally as sociated with severe histological abnormalities and rapid progression of the disease. To assess the efficacy of recombinant interferon-a2b i n treatment of chronic delta hepatitis, 22 patients were entered into a randomized controlled trial: 11 received interferon-a2b subcutaneous ly three times weekly for 12 months (5 MU/m(2) for 4 months and then 3 MU/m(2) for a further 8 months) and 11 were untreated. All patients w ere followed up for 6 months after the completion of therapy. Nine tre ated patients completed the trial: one was withdrawn with hyperthyroid ism and one committed suicide. Serum ALT levels were normalized or sig nificantly reduced, always within 3 months of initiating treatment, an d remained so in 73% of treated patients at the 4th month and in 54.5% at the 12th month, compared with 18% and 18%, respectively, in the un treated group. Moreover, in seven of nine treated patients, interferon was associated with the clearance of serum HDV-RNA, associated with a melioration of the histological picture, whereas this occurred in only four of 11 untreated patients. On cessation of therapy, all patients but one experienced a biological and/or virological relapse over the 6 -month follow up. In conclusion, our data confirm that HDV is sensitiv e to inhibition by interferon-a2b, although the schedule used did not achieve permanent control of the disease. The adverse effects of inter feron require consideration; in particular, care will be needed to avo id serious psychiatric side effects.